JP5743128B2 - Methods and systems for translaminar spinal fixation - Google Patents

Description

Disclosure details

[Field of use]
The present disclosure relates to spinal fixation procedures, and more particularly, to methods and systems for fixing and positioning a spinal fixation assembly within a vertebra.

〔background〕
A spinal fixation procedure is used to align and / or fix a desired relationship between adjacent vertebral bodies. Such a procedure typically includes positioning a plurality of spinal fixation assemblies within a target vertebra. These assemblies typically include a threaded shank portion configured to be placed (eg, screwed) within a vertebra, and a rigid rod, cable, biological structure, etc. A proximal receiving head configured to receive and secure a type of spinal stabilization element. Once these assemblies are placed in the desired vertebra, the spinal stabilization rod can be positioned and secured within the receiving head so that the rod runs along the length of the patient's spine. It is possible to extend. Once so fixed, the installed spinal stabilization rod can hold the vertebrae in the desired spatial relationship until the desired healing or spinal fusion occurs or for a somewhat longer period of time.

  Due to the complexity of working close to the spinal column, such procedures can cause serious patient damage and / or serious patient trauma. For example, such a procedure typically requires that the spinal fixation assembly be delivered directly into the outer mass of the target vertebra (ie, substantially perpendicular to the midline of the patient's spine). And Taking this trajectory into account, a significant amount of muscle and tissue must be removed from the treatment site due to the relatively long distance between the entry point of the outer mass and the midline of the spine. Also, any slight miscalculation in the delivery trajectory can cause penetration of the distal portion of the assembly (eg, pointed tip) into the spinal canal, thereby causing serious patient damage. . As a further disadvantage, the limited bone mass and / or bone density typically found in the outer mass portion of the vertebra significantly limits the amount of area available to contact the fixation assembly, thereby This impedes the ability to effectively position the fixation assembly within the vertebra.

  Accordingly, there is a need for methods and systems that can fix and position a fixation assembly within a target vertebra while also minimizing the risk of injury and associated patient trauma.

〔Overview〕
Disclosed herein are methods and systems that effectively position a spinal fixation assembly within a target vertebra while reducing any associated patient trauma (eg, muscle removal, tissue damage, etc.). The More specifically, the embodiments disclosed in the present invention use trans-lamina delivery and positioning of the fixation assembly within the target vertebra. As described below, translaminar delivery offers numerous advantages over traditional direct delivery techniques. For example, translaminar delivery can significantly increase the surface area of the vertebrae available to contact the fixation assembly, thereby allowing for a stronger and more stable fixation (e.g., Allows the use of a longer and / or wider fixing assembly. In addition, translaminar delivery and positioning of the fixation assemblies within the vertebrae allows each fixation assembly to be in close proximity to the midline of the patient's spine, as opposed to traditional direct delivery techniques. The vertebra can be entered, so that there is very little tissue and / or muscle damage. The translaminar trajectory also reduces the risk of damage caused by the assembly penetrating into the spinal canal. This is because, in contrast to traditional direct delivery techniques, the assembly is not delivered along a substantially vertical trajectory, but rather is angled away from the patient's spinal column during delivery. It is because it can be made.

  Various aspects of a method for providing spinal stabilization are disclosed herein. In one such embodiment, the method positions the first fixation assembly within the first vertebra with the translaminator orientation and the second fixation assembly within the second vertebra with the translaminator orientation. Positioning the proximal receiving head of the first securing assembly with the proximal receiving head of the second securing assembly. The method then positions the spinal stabilization element within the proximal receiving head of both the first fixation assembly and the second fixation assembly, and the stabilization element (eg, rod), respectively. Securing within the proximal receiving head of the device.

  As required by any given procedure, the fixation assembly can be positioned in any number and / or type (eg, cervical, breast, lumbar) vertebrae. The method can also include positioning the fixation assembly in various ways to optimize the orientation of the stabilization element (eg, stabilization rod) relative to the patient's spine. For example, in one such embodiment, the proximal receiving heads of the various fixation assemblies can be positioned along and above the midline of the patient's spinal column, thereby A stabilizing element can be coupled to the proximal receiving head, which allows the stabilizing element to be positioned along and above the midline of the patient's spinal column. In other embodiments, the proximal receiving head of each of the first plurality of fixation assemblies can be positioned along one side of the midline of the patient's spinal column, and the second plurality Each proximal receiving head of the fixation assembly can be positioned on opposite sides of the midline of the patient's spine. In such embodiments, the first stabilization element can be coupled to the receiving head of each of the first plurality of fixation assemblies, and the second stabilization element can be the second stabilization element. A proximal receiving head of each of the plurality of fixation assemblies can be coupled. Thereby, the stabilizing elements can be positioned on both sides of the midline of the patient's spine. Thus, translaminar delivery and positioning of such a fixation assembly allows for improved stability and versatility in positioning the stabilizing element relative to the patient's spinal column.

  The method can also include various procedures to further optimize delivery and positioning of the fixation assembly within the vertebra. For example, the method can include removing various portions of at least one (or all) target vertebrae prior to engagement of the fixation assembly. Such truncation can more accurately position the proximal end of the fixation assembly relative to the stabilization element by accessing the optimal portion of the vertebra and / or Can be used to facilitate engagement. For example, the method can include removal or cutting of a spinous process of the vertebra, thereby positioning the proximal end of the assembly along the midline of the patient's spine Is possible.

  The spinal fixation assembly can be configured in various ways. Generally, the assembly is any type of set that is configured to be fixedly engaged with a vertebra and also has a proximal portion that is configured to fixably receive a stabilizing element. Solids can be included. For example, the fixation assembly can include a bone anchor element (eg, a bone screw) having a proximal end coupled to a receiving head configured to receive and secure a stabilizing element. In the exemplary embodiment, the receiving head is movably coupled to the bone anchor element. For example, the receiving head can be multiaxially moved relative to the bone anchor. Additionally, the receiving head can be configured in virtually any manner capable of receiving and securing the stabilizing element. In an exemplary embodiment, the receiving head can include a “U-shaped” opening configured to receive a stabilizing element. In such an embodiment, the U-shaped opening of the receiving head is a variety of internal threads configured to receive any type of closure mechanism (eg, set screw) having a corresponding set of screws. (Or other engagement means) can be included so that the stabilizing element can be secured to the assembly.

  In another aspect, a method is provided for providing spinal stabilization, the method comprising positioning a plurality of fixation assemblies within a plurality of vertebrae, wherein the fixation assembly is in a translaminator orientation, Positioned on. In an exemplary embodiment, each fixation assembly can include a threaded shank with a proximal end that is polyaxially coupled to the receiving head. Next, the method includes securing the first stabilizing element within the receiving head of the first securing assembly and within the receiving head of the second securing assembly, whereby the patient A stabilizing element can be positioned adjacent to the midline of the spinal column. Optionally, the method also includes securing a second stabilizing element within the receiving head of the third securing assembly and within the receiving head of the fourth securing assembly, whereby The second stabilizing element can be positioned adjacent to the midline of the patient's spinal column and the second stabilizing element is on the opposite side of the midline as compared to the first stabilizing element. Positioned on.

  Various aspects of systems that provide spinal stabilization are also disclosed herein. In one such embodiment, the system includes a plurality of fixation assemblies fixed to the plurality of vertebrae in a translaminar orientation, each fixation assembly being a bone anchor movably coupled to the receiving head. Contains elements. The system further includes a stabilizing element (eg, rod, cable, etc.) that can be secured within a plurality of such receiving heads so that the stabilizing element is relative to the midline of the patient's spine. Can be positioned in a substantially parallel orientation. As described above, the stabilizing element can be positioned at various locations relative to the patient's spinal column. For example, the system can include a stabilizing element positioned along and above the midline of the patient's spine. In other embodiments, the system can include a stabilizing element positioned adjacent to the midline of the patient's spinal column. For example, the system can include a first spinal stabilization element and a second spinal stabilization element positioned on both sides of the midline of the patient's spinal column.

  These and other aspects of the methods and systems disclosed in the present invention are described in detail below.

  The embodiments disclosed herein will be more fully understood from the following detailed description taken in conjunction with the accompanying drawings.

[Detailed explanation]
For a comprehensive understanding of the principles of structure, function, manufacture, and use of the systems and methods disclosed herein, some exemplary embodiments will be described below. One or more examples of these embodiments are illustrated in the accompanying drawings. As will be appreciated by one skilled in the art, the systems and methods described herein and illustrated in the accompanying drawings are non-limiting exemplary embodiments and The scope is defined only by the claims. The features illustrated or described in connection with one exemplary embodiment may be combined with other embodiments. Such modifications and variations are intended to be included within the scope of the present disclosure.

  Disclosed herein are methods and systems for spinal stabilization using translaminar delivery and positioning of a fixation assembly within a target vertebra. In contrast to traditional direct delivery into the outer mass of the fixation assembly, translaminar delivery increases the amount of vertebrae available to receive the fixation assembly, thereby increasing the strength. Provides fixed and improved treatment results. Also, the greater amount of vertebra available enables the use of larger (eg, longer and / or wider) fixation assemblies that facilitate stronger fixation. Translaminar delivery and positioning the fixation assembly also significantly reduces the amount of tissue and / or muscle damage caused by this procedure. This is because, compared to traditional direct delivery procedures, the fixation assembly can enter the target vertebra at a location very close to the midline of the patient's spine. As a further advantage, the delivery trajectory made available by such translaminar delivery and positioning reduces the potential for inadvertent damage to the spinal column and / or surrounding areas. The reason is that the assembly can be angled away from the patient's spine during delivery.

1A and 1B illustrate a traditional spinal fixation technique, where the fixation assembly 10 is delivered and positioned directly within the outer mass (LM) of the target vertebra V ₁ . As shown, direct delivery of the fixation assembly 10 to the outer mass (LM) significantly limits the usable entry point (E) of the fixation assembly 10. This is because the user must protect the fixation assembly 10 from penetrating the spinal canal (SC) and / or surrounding nerves. As shown, any slight miscalculation in the delivery trajectory also may cause undesirable introduction into the spinal canal of the distal end 10 _D of the assembly 10 (S.C.). In addition, traditional approaches typically cause significant tissue damage, because only a relatively long distance (D ₁ ) from the midline (ML) of the patient's spine This is because the fixation assembly 10 must be delivered to the vertebra V ₁ at a remote entry point (E). Thus, in order to access the entry point (E), the procedure requires a significant amount of muscle and / or tissue removal. A further disadvantage is that the procedure typically involves fixing assemblies having a relatively short length (L ₁ ), given the relatively small amount of vertebrae present in the outer mass (LM). It is limited, thereby preventing the ability to provide strength fixed between the vertebrae V ₁ of the assembly 10 and the target.

In contrast, FIG. 2 shows an exemplary embodiment of the method disclosed in the present invention, where the spinal fixation assembly 10 is delivered into the target vertebra V ₁ in a translaminar orientation. Positioned. That is, the fixation assembly 10 is delivered across the laminar portion of the vertebra V ₁ and into the outer mass (LM). As described, such a trajectory allows at least a portion of the fixation assembly to be positioned over the midline (ML) of the patient's spinal column (SC). be able to. For example, in those procedures that require the stabilization rod to be positioned away from the midline (ML) of the spinal column (as shown in FIGS. 2 and 3A), the fixation assembly is , Can be delivered and positioned in vertebra V ₁ in translaminar orientation, so that the threaded shank 12 of the fixation assembly 10 is the midline (ML) of the spinal column (SC). Crosses over. Similarly, in those procedures that require placing a stabilizing rod along the midline (as shown in FIGS. 4A-4B) over the midline, translaminar delivery is fixed. The proximal receiving head of assembly 10 can be allowed to be positioned substantially above the midline (as shown in FIG. 5).

The translaminar fixation procedure disclosed in the present invention provides a number of benefits when compared to the direct delivery approach described above. For example, such trans-lamina delivery and positioning is between vertebrae V ₁ corresponding to the fixed assembly 10 allows for more intense fixation. The reason is that a larger surface area and / or denser bone mass can be used to receive and engage the fixation assembly 10. Taking into account the enlarged surface area, the fixation assembly 10 can include larger (eg, longer and / or wider) bone anchor elements 12 that aid in stronger fixation. In addition, translaminar delivery and positioning significantly reduces the risk of damage. The reason is that, in contrast to the prior art trajectory substantially perpendicular to the spine (S.C.), the distal end of the fixation assembly 10 _D is spinal canal during delivery (S. This is because an angle can be formed in a direction away from C.). In addition, when using translaminar delivery and positioning, the assembly 10 can be compared with the distance required when using traditional direct delivery techniques (D ₁ shown in FIG. 1A) in the spine. The vertebra V ₁ can be entered at the translaminar entry point (E ′), which is a substantially shorter distance (D ₂ ) from the line (ML). Therefore, as disclosed in the present invention, trans-lamina delivery and positioning of the vertebrae V ₁ of the fixing assembly 10, when compared to traditional approaches, relevant tissue, and / or to significantly reduce muscle damage .

As will be appreciated by those skilled in the art, the fixation assembly 10 includes a distal portion 12 configured to engage the vertebra V ₁ and a type of spinal stabilization element (eg, stabilization). It can be virtually any type of assembly having a proximal portion 14 configured to securely receive a rod. For example, referring again to FIG. 2, the fixed assembly 10 may include a bone anchor element 12 that is configured to engage to secure the vertebrae V _1. As will be appreciated by those skilled in the art, the bone anchor element 12 may be any type of element configured to engage a vertebra. In the exemplary embodiment, bone anchor element 12 is a bone screw 12 having a thread extending along a portion of screw 12 so that element 12 is effectively delivered and secured within vertebra V ₁ . Allowing them to be positioned. The bone anchor element 12 can include various ranges of sizes and / or shapes, and as described above, the advantages of translaminar delivery use a larger element 12 when compared to traditional approaches. Be able to. For example, FIG. 2 shows an embodiment of a bone anchor element 12 having a length (L ₂ ) that is substantially longer than the bone screw length (L ₁ ) used in the traditional technique shown in FIG. 1B. .

Referring again to FIG. 2, the proximal portion 14 of the fixation assembly 10 is configured in various ways for fixedly engaging a spinal stabilization element (eg, a stabilization rod). For example, the fixed assembly 10 may include a bone anchor element 12 receiving head 14 coupled to the proximal end of _P. Such a receiving head 14 can be configured to immobilize and receive a spinal stabilization element in various ways. For example, in the exemplary embodiment, receiving head 14 may include a “U” shaped opening 16 configured to receive a stabilizing element. In other embodiments, the opening 16 can include a variety of other shapes that can receive a stabilizing element. The receiving head 14 can also be configured in various ways to secure the stabilizing element therein. For example, the receiving head 14 can include various internal threads (not shown) that can receive the closure mechanism 13 (see FIG. 3A), thereby securing the stabilizing element within the receiving head 14. be able to. As will be appreciated by those skilled in the art, the receiving head 14 can be configured in various ways to hold the stabilizing element therein.

The fixation assembly 10 can also be configured to allow movement of the receiving head 14 relative to the bone anchor element 12. The receiving head 14 can be coupled to the bone anchor element 12 in any number of ways to provide any desired motion and / or range of motion, although in the exemplary embodiment The head 14 is capable of multi-axis movement with respect to the element 12. As will be understood by those skilled in the art, the receiving head 14, and / or the proximal end 12 _P of the bone anchor element 12 in order to provide such a multi-axis motion, various such Can be configured and / or combined. In other embodiments, the fixation assembly 10 can be configured to allow the receiving head 14 to be rotated relative to the bone engaging element 12, thereby providing a variety of receiving heads. The 14 openings 16 allow to be aligned with each other prior to delivery of the stabilizing element.

  As shown in FIGS. 3A-4B, following the positioning of the translaminers of the various fixation assemblies 10, one or more stabilizing elements (e.g., stabilizing elements) may be provided to provide the desired therapeutic effect. Rod) can be fixed to the fixing assembly. As will be apparent to those skilled in the art, the stabilizing element 20 can be a rod, cable, biological structure, or the like. Further, the stabilizing element 20 can have various ranges of dimensions (eg, length and / or diameter) and / or shape (eg, straight, curved, etc.) that are Selected according to patient anatomy and / or surgical procedure requirements. As also shown, the method comprises a first stabilizing element and a first stabilizing element on both sides of the patient's spinal midline (ML) (as shown in FIGS. 3A-3B). Positioning the second stabilizing element, or the method is along the midline (ML) of the patient's spinal column (as shown in FIGS. 4A-4B). Positioning a stabilizing element on the center line of the lever. These treatments are described in more detail below.

FIGS. 3A and 3B illustrate a plurality of fixation assemblies 10 ′, 10 ″, 10 ′ ″, 11 ′, 11 ″, 11 ″ delivered and positioned within the target vertebra in a translaminar orientation. 2 illustrates an exemplary embodiment including '. As will be understood by those skilled in the art, these fixation assemblies 10 ', 10'',10''', 11 ', 11'',11''' is the vertebra V ₁ of the arbitrary pattern , V ₂ , V _n (eg, all vertebrae, every other vertebra, every third vertebra, etc.). For example, referring to FIG. 3A, the method applies a first plurality of fixation assemblies 10 ′, 10 ″, 10 ′ ″ to a plurality of vertebrae V ₁ , V ₃ , V ₅ in a translaminator orientation. Engaging, whereby the proximal portion of these assemblies 10 ′, 10 ″, 10 ′ ″ is adjacent to the midline (ML) of the patient's spinal column. Be placed. The method may further include delivering a second plurality of fixation assemblies 11 ′, 11 ″, 11 ′ ″ to the plurality of vertebrae V ₂ , V ₄ , V ₆ in a translaminar orientation. The proximal portion of these assemblies 11 ′, 11 ″, 11 ′ ″ can be adjacent to the midline (ML) of the patient's spinal column and the first plurality Compared to the fixing assemblies 10 ′, 10 ″, 10 ′ ″, they are arranged on opposite sides of the midline (ML). Once positioned in this manner, the first stabilizing element 20 is positioned and secured within the proximal ends of the first plurality of securing assemblies 10 ′, 10 ″, 10 ′ ″. Also, the second stabilizing element 20 ′ can be positioned and secured within the proximal end of the second plurality of securing assemblies 11 ′, 11 ″, 11 ′ ″. Thus, as shown in FIG. 3A, the embodiment includes a first stabilizing element 20 and a second stabilizing element 20 positioned on both sides of the midline (ML) of the patient's spine. 'And the first stabilizing element 20 and the second stabilizing element 20' are substantially parallel to the midline (ML) of the spinal column. In other embodiments, the method includes placing only one of the plurality of fixation assemblies 10 ′, 10 ″, 10 ′ ″ on one side of the patient's spinal midline (ML). Positioning along.

As described above, the method disclosed in the present invention, the fixation assembly 10 of any number of vertebrae V ₁ of the any number and / or pattern, to allow the positioning and delivery. For example, as shown in FIG. 3A, the first plurality of fixation assemblies 10 ′, 10 ″, 10 ′ ″ are in the direction of a translaminator and every other vertebra V ₁ , V ₃ , V _5. Can be positioned within. Additionally, the second plurality of fixation assemblies 11 ′, 11 ″, 11 ′ ″ may also be positioned in every other vertebra V ₂ , V ₄ , V ₆ in the translaminar orientation. And staggered with respect to the first plurality of fixing assemblies, whereby six fixing assemblies 10 ′, 10 ″, 10 ′ ″, 11 ′, 11 ″, Each of 11 ″ ′ is positioned in a different vertebra V ₁ -V ₆ . In other embodiments, the method includes any number of fixation assemblies (eg, 2, 3, 4, 5, 5) configured to receive and secure any desired length of stabilizing element 20. 6). Additionally, as shown in FIG. 3B, the method includes at least one fixation assembly of the first plurality of fixation assemblies 10 ′ and at least one of the second plurality of fixation assemblies 11 ′. Delivery of the fixation assembly to the same vertebra V ₁ along the translaminar trajectory. Additionally, the first plurality of fixing assemblies 10 ′, 10 ″, 10 ′ ″ and / or the second plurality of fixing assemblies 11 ′, 11 ″, 11 ′ ″. The volume can be fixed to a continuous vertebra, every other vertebra, every third vertebra, or any other pattern that is required and / or preferred for a given procedure. it can. Such versatility allows the surgeon to select the optimal vertebra location for delivery and positioning of the fixation assembly and stabilizing element.

In other exemplary embodiments, the method may include the use of a single stabilizing element 20 positioned along and above the midline (ML) of the patient's spine. 4A and 4B provide an example of such an embodiment, in which a plurality (eg, four) of fixation assemblies 10, 10 ′, 10 ″, 10 ′ ″ Delivered in translaminar orientation relative to successive vertebrae V ₁ , V ₂ , V ₃ , V _{4 so} that the proximal portion of each assembly 10, 10 ′, 10 ″, 10 ′ ″ , Substantially aligned with and above the midline (ML) of the patient's spinal column. As described above, the fixation assemblies 10, 10 ′, 10 ″, 10 ′ ″ can be vertebrae in various patterns and / or configurations to position the proximal portion of the assembly at a desired location. Can be delivered to. For example, as shown in FIGS. 4A and 4B, a fixation assembly 10, 10 ′, 10 ″, 10 ′ ″ is delivered so that each bone anchor has a continuous vertebra V ₁ , V _2. , V ₃ , V ₄ can be angled in the opposing direction of adjacent bone anchors. In other embodiments, as described above, the fixation assemblies 10, 10 ′, 10 ″, 10 ′ ″ may be delivered to every other vertebra, every third vertebra, and the like. it can. Also, any number of fixation assemblies 10, 10 ′, 10 ″, etc. can be used based on the patient's anatomy and / or treatment requirements. For example, the method can use two, three, four, five or more fixation assemblies 10. In essence, the method includes any number and / or number of fixations positioned in a translaminar orientation within any number and / or pattern of target vertebrae to securely position at least one stabilizing element in a desired location. An assembly can be included.

Various embodiments of the method can also be used to further optimize the treatment, to change the various portions of the vertebra V ₁ of the target, and / or may be cut. More specifically, removal of the various portions of the target vertebra V ₁ can provide access to the optimal entry point of the vertebra and can also provide a proximal end of the fixation assembly 10 where desired. Can be easily positioned. For example, FIGS. 4A, 4B and 5 provide one exemplary embodiment in which various vertebrae (V ₁ -V ₄ in FIGS. 4A-4B, V in FIG. 5) are provided. ₁ ) portion is removed or cut so that the proximal portion of each fixation assembly 10 is positioned above the midline along the midline (ML) of the patient's spine To be able to. Additionally, removing these portions of the target vertebra V ₁ can provide an easier target for delivery of the fixation assembly 10. The reason is that the cut vertebra V ₁ is substantially planar, and therefore it can be easier to engage the assembly 10 with this cut vertebra V _1. . As will be apparent to those skilled in the art, the method can include removing any portion of these V ₁ as required by the given procedure. As shown in the exemplary embodiments of FIGS. 4A, 4B, and 5, the method may also remove (or cut) the spinous processes of all (or at least one) vertebra V _1. Can be included.

Various embodiments of a system for providing spinal stabilization are also disclosed herein. In the exemplary embodiment, the system includes a plurality of fixation assemblies 10 ′, 10 ″, 10 ′ ″ engaged with a plurality of vertebrae V ₁ , V ₂ , V _3, etc. in a translaminar orientation. Each fixation assembly 10 includes a bone anchor element (eg, bone screw) 12 coupled to a movable receiving head 14. The system can further include a stabilizing element (eg, rod, cable, etc.) 20 secured within a plurality of such movable heads 14 so that the stabilizing element 20 can be Maintain a substantially parallel orientation with respect to the midline (ML). As described above, the stabilizing element 10 can be positioned at various locations relative to the patient's spinal column (SC). For example, the system can include a stabilizing element 20 positioned along and above the midline (ML) of the patient's spinal column. In other embodiments, the system can include a stabilizing element 20 positioned adjacent to the midline (ML) of the patient's spinal column. For example, the system can include a first spinal stabilization element 20 and a second spinal stabilization element 20 'positioned on both sides of the midline (ML) of the patient's spinal column.

  One skilled in the art will appreciate further features and advantages of the methods and systems disclosed in the present invention based on the above-described embodiments. Accordingly, the disclosure of the present invention is not limited by what has been particularly shown and described, except as defined by the appended claims. All publications and references cited herein are hereby expressly incorporated by reference in their entirety.

Embodiment
(1) In a method for providing spinal stabilization,
Positioning the first fixation assembly within the first vertebra in a translaminar orientation;
Positioning the second fixation assembly within the second vertebra in a translaminar orientation so that the proximal receiving head of the first fixation assembly is the proximal receiving head of the second fixation assembly Being aligned with the department,
Positioning a spinal stabilization element within the proximal receiving head of both the first fixation assembly and the second fixation assembly;
Securing the spinal stabilization element within each proximal receiving head;
Including a method.
(2) In the method according to embodiment 1,
The method wherein the proximal receiving head of each fixation assembly is positioned along and above the midline of the patient's spine.
(3) In the method according to embodiment 1,
The method wherein the proximal receiving head of each fixation assembly is positioned adjacent to the midline of the patient's spinal column.
(4) In the method according to embodiment 1,
Removing a portion of at least one vertebra,
Positioning the fixation assembly within the at least one vertebra in a translaminar orientation;
Further comprising a method.
(5) In the method according to embodiment 4,
The method wherein the spinous process of the vertebra is removed.
(6) In the method according to embodiment 5,
The method wherein the proximal receiving head of each fixation assembly is positioned along and above the midline of the patient's spine.
(7) In the method according to Embodiment 1,
The method wherein the fixation assembly is positioned in an adjacent vertebra.
(8) In the method according to embodiment 1,
The method wherein the fixation assembly is positioned in non-adjacent vertebrae.
(9) In the method according to embodiment 1,
A method, wherein each receiving head is configured for multi-axis motion.
(10) In the method according to embodiment 1,
Each receiving head includes a U-shaped opening configured to securely receive a stabilizing element.

(11) In a method for providing spinal stabilization,
Locating a plurality of fixation assemblies within a plurality of vertebrae, wherein the fixation assemblies are positioned within the vertebrae in a translaminar orientation, each fixation assembly being polyaxially mounted on a receiving head. Locating a plurality of fixation assemblies having a threaded shank with coupled proximal ends;
A first stabilizing element is secured within the receiving head of the first securing assembly and within the receiving head of the second securing assembly, thereby adjacent the midline of the patient's spine. Positioning the stabilizing element;
Including a method.
(12) In the method according to embodiment 11,
A second stabilizing element is secured within the receiving head of the third securing assembly and within the receiving head of the fourth securing assembly, whereby the second stabilizing element is Positioning adjacent to the midline of the patient's spinal column and positioning the second stabilizing element on opposite sides of the midline as compared to the first stabilizing element;
Further comprising a method.
(13) In the method according to embodiment 11,
The method wherein the first stabilizing element and the second stabilizing element are stabilizing rods.
(14) In the method according to embodiment 11,
The method, wherein at least one of the plurality of vertebrae is a cervical vertebra.
(15) In the method according to embodiment 11,
The method, wherein the stabilizing element extends along at least three vertebrae.

(16) In a system for providing spinal stabilization,
A plurality of fixation assemblies, each fixation assembly configured to be implanted in a vertebra in a translaminar orientation, each fixation assembly coupled to a movable receiving head A plurality of fixation assemblies having bone engaging elements;
A stabilizing element secured within each movable receiving head so that the stabilizing element maintains an orientation substantially parallel to the midline of the patient's spine And
Including the system.
(17) In the system according to embodiment 16,
The stabilization element is configured to be positioned along and above the midline of the patient's spinal column.
(18) In the system according to embodiment 16,
The system, wherein the stabilizing element is configured to be positioned adjacent to the midline of the patient's spinal column.
(19) In the system according to embodiment 18,
A second stabilizing element, secured within a second plurality of movable receiving heads, whereby the second securing assembly is adjacent to the midline of the patient's spinal column. And the second fixation assembly is configured to be positioned on an opposite side of the midline with respect to the first spinal stabilization element. ,
Further including a system.
(20) In the system according to embodiment 16,
The system, wherein the stabilizing element is a rod.

FIG. 3 is a perspective view of a prior art procedure in which the fixation assembly is delivered directly into the outer mass of the target vertebra. 1B is another view of the direct delivery technique illustrated in FIG. 1A. FIG. FIG. 10 shows a fixation assembly positioned within a target vertebra in a translaminar orientation. FIG. 5 is an illustration of an embodiment in which multiple fixation assemblies are positioned within a vertebra in a translaminar orientation. FIG. 10 is an illustration of another embodiment in which multiple fixation assemblies are positioned within a vertebra in a translaminar orientation. FIG. 6 is a perspective view of an embodiment in which a spinal stabilization element is positioned along and above the midline of a patient's spinal column. FIG. 4B is a side view of the embodiment of FIG. 4A. FIG. 6 is an illustration of an embodiment in which a portion of the vertebra is cut prior to translaminator delivery and positioning of the fixation assembly.

Claims (5)

In a system that provides spinal stabilization,
A plurality of fixation assemblies, each fixation assembly configured to be implanted in a vertebra in a translaminar orientation, wherein each fixation assembly is a proximal portion of a bone engaging element The bone engaging element has a maximum outer diameter that is less than the thickness of the laminator, and the bone engaging element comprises the bone engaging element. A distal portion of the element is positioned across the midline of the patient's spine and opposite the receiving head, and the distal portion extends into the outer mass (LM) of the vertebra A plurality of fixation assemblies having a longitudinal length sufficient to extend across the laminar;
A stabilizing element secured within each movable receiving head so that the stabilizing element maintains an orientation substantially parallel to the midline of the patient's spinal column A stabilizing element,
Including the system. In a system that provides spinal stabilization,
A plurality of fixation assemblies, each fixation assembly configured to be implanted in a vertebra in a translaminar orientation, wherein each fixation assembly is a proximal portion of a bone engaging element The bone engaging element has a maximum outer diameter that is less than the thickness of the laminator, and the bone engaging element comprises the bone engaging element. A plurality of fixation assemblies having a longitudinal length sufficient to extend across the laminar such that a distal portion of an element extends into the outer mass (LM) of the vertebra; ,
A stabilizing element secured within each movable receiving head so that the stabilizing element maintains an orientation substantially parallel to the midline of the patient's spinal column A stabilizing element,
Including
The stabilization element is configured to be positioned along and above the midline of the patient's spinal column. The system of claim 1, wherein
The system, wherein the stabilizing element is configured to be positioned adjacent to the midline of the patient's spinal column. The system of claim 3, wherein
A second stabilizing element secured within the second plurality of movable receiving heads, whereby the second securing assembly is adjacent to the midline of the patient's spinal column A second stabilizing element positioned and configured such that the second securing assembly is positioned on the opposite side of the midline with respect to the first stabilizing element;
Further including a system. The system of claim 1, wherein
The system, wherein the stabilizing element is a rod.

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